HOMBRE: A randomized controlled trial to compare two approaches to weight loss for overweight and obese Latino men (Hombres con Opciones para Mejorar el Bienestar y bajar el Riesgo de Enfermedades crónicas; men with choices to improve well-being and decrease chronic disease risk).

Latino men bear a disproportionate burden of obesity, diabetes, and cardiovascular disease.However, limited behavioral lifestyle intervention research has focused on Latino men. This trial compares two approaches to weight loss for overweight and obese Latino men: 1) HOMBRE is a culturally adapted intervention that provides individual choice of either self-directed online videos, coach-facilitated in-person groups, and coach-facilitated online groups; and 2) a minimal intensity intervention that uses online videos with a coach available, if solicited by the participant.Latino men with a Body Mass Index (BMI) of ≥27 kg/m and one or more cardiometabolic risk factors (n = 424) will be randomly assigned to receive one of the two approaches.The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework guides the planned evaluations.The primary aim is to determine the effectiveness of the HOMBRE intervention (the "E" in RE-AIM) on clinically significant weight loss (≥5% of baseline weight) at 18 months. We hypothesize that a significantly higher proportion of HOMBRE participants will maintain ≥5% of weight loss compared with those in the minimal intensity intervention.Secondary aims are to determine the effectiveness of HOMBRE on cardiometabolic risk factors (e.g., blood pressure, waist circumference), health behaviors (e.g., diet and physical activity), and psychosocial well-being (e.g., quality of life and depressive symptoms) and to evaluate the other attributes of RE-AIM. These findings have real word applicability with value to clinicians, patients, and other decision makers considering effective diabetes prevention programs for Latino men in primary care.

Copyright © 2018. Published by Elsevier Inc.